Plattsburgh,
NY, USA -- Monaghan Medical Corporation understands that for
those with asthma, particularly children, choosing the device that
best delivers their medication is an important consideration.
Research has shown that even when using the same metered-dose inhaler
(MDI), not all valved holding chambers perform equally well.[1]
A
landmark real-world study involving more than 18,000 asthma patients
has demonstrated superior asthma control with the AEROCHAMBER PLUS®
FLOW-VU® antistatic Valved Holding Chamber (VHC) compared with other
chamber devices.[2] According to the study, published in Pulmonary
Therapy, use of the AEROCHAMBER PLUS® FLOW-VU® antistatic chamber
resulted in delayed time to first exacerbation, fewer asthma-related
emergency department visits, and lower exacerbation-related costs
than control chambers.
Asthma
is a common respiratory condition that affects an estimated 24.6
million people in the United States. Almost half of them, including
nearly 3 million children, experience one or more asthma attack in a
year.[3]
As
opposed to systemic medications, inhalation is the recommended way to
administer asthma medications because it directly targets the drug to
the lungs while reducing potential side effects. Inhaled
corticosteroids and bronchodilators administered by MDIs are the
mainstay of long-term asthma treatment, the goals of which are to
improve symptoms and prevent the occurrence of exacerbations.[4]
Poor
inhaler operation by users is common, resulting in less of the
delivered drug reaching the lungs. Instead, much of it is deposited
on the back of the throat (oropharyngeal deposition) and then
swallowed.[5] Research shows that between 28% and 68% of patients do
not use inhalers well enough to benefit from prescribed
medication.[6] In addition, 25% of costs associated with inhalers is
wasted due to poor inhaler technique.[6]
Chambers
are designed to reduce oropharyngeal deposition by changing the
particle size distribution of the inhaled aerosol, and by holding the
aerosol in the chamber until the patient is ready to inhale, which
reduces the need for good coordination between inhalation and inhaler
actuation.[7] Effectiveness of these devices can be adversely
affected by the design, including the chamber electrostatic charge, a
commonly reported cause of inconsistent medication delivery.[8]
Global
respiratory guidelines recommend the use of chambers to improve MDI
drug delivery.[4] American Thoracic Society and American Association
for Respiratory Care Clinical Practice Guidelines state that the
addition of a chamber is recommended and helpful.[9,10] Research also
indicates that patients who use a chamber with an MDI have better
asthma control than those using an MDI alone.[11]
In
this new study, Dr. Chakkarin Burudpakdee (QuintilesIMS, Fairfax, VA,
USA) and colleagues compared the effects of the antistatic
AEROCHAMBER PLUS® FLOW-VU® aVHC and control chambers on treatment
outcomes, resource use, and healthcare costs in a real-world asthma
population.[2] More than 18,000 patients were included from an
adjudicated claims database containing medical and pharmacy claims
for more than 150 million U.S. health plan members.[2]
The
analysis showed that among patients with at least 30 days of
follow-up, those using the AEROCHAMBER PLUS® FLOW-VU®
antistatic VHC experienced a delay in the time to first exacerbation
and had fewer asthma-related emergency room visits. In addition,
exacerbation-related costs were lower when compared to those using
the control (non-antistatic) chambers.[2] A trend toward lower
exacerbation rates per patient for the AEROCHAMBER PLUS® FLOW-VU®
aVHC was sustained throughout the 12 months of the study.[2]
"This
landmark study using a large volume of real-world evidence generated
from thousands of patients shows the value of optimizing drug
delivery in asthma management and further supports that chambers are
not interchangeable," said co-author Dominic Coppolo, MBA, RRT,
FAARC, Vice President Clinical Strategy and Development. "The
reduction in exacerbation incidents among users of the AEROCHAMBER
PLUS® FLOW-VU® chamber is particularly notable because
experiencing an exacerbation is a risk factor for future exacerbation
events-and minimizing exacerbation risk is a key goal of treatment."
"The
European Medicines Agency recommended in 2009 that development of a
MDI should include the testing of at least one specific, named
chamber, and that any substitution must be supported by appropriate
in vitro or clinical data demonstrating equivalence," he said.
"We presented laboratory data at the recent Respiratory Drug
Delivery Europe meeting[2] that confirmed that not all chambers
perform equally well with the same MDI, which underlines the
importance of recognizing the impact and potential risks of
substituting one device for another."
About
Monaghan Medical Corporation
Monaghan
Medical Corporation (MMC) offers leading aerosol drug delivery
devices and respiratory management products including AeroEclipse®
II BAN, AeroChamber Plus® aVHC and the Aerobika®
device exclusively in the United States. MMC's strength lies in
product development around core capabilities in mechanical design
complimented by collaboration with a state-of-the-art aerosol
research laboratory. MMC focuses on developing cost-efficient,
outcome-based solutions for its customers.
(http://www.monaghanmed.com)
About
AEROCHAMBER® brand valved holding chambers, including the
AEROCHAMBER PLUS® FLOW-VU® anti-static chamber
Developed
in 1983 to address the needs of asthma and COPD patients having
difficulty in taking their MDI medications correctly, the
AEROCHAMBER® brand of chamber has innovated continuously to improve
patient ease of use and quality of life as well as clinical outcomes
and healthcare system savings.
• The
AEROCHAMBER PLUS® valved holding chamber is the leading global
chamber brand, with safety and efficacy validated in numerous
third-party clinical evaluations among various patient populations.
It is the chamber most recommended by leading MDI pharmaceutical
companies.
• AEROCHAMBER
PLUS® FLOW-VU® chamber is an antistatic chamber designed to deliver
the intended prescribed dose via the MDI, similar to using an MDI
with perfect technique. An additional feature is the incorporation of
the FLOW-VU® inhalation indicator for the caregiver to observe
effective inhalation. A recent study showed that caregiver quality of
life improved almost four-fold when using the AEROCHAMBER PLUS®
chamber with FLOW-VU® indicator versus the same chamber without the
indicator.[12] The FLOW-VU® indicator provides real-time feedback
confirming an effective inhalation and that there are no leakages of
ambient air into the space between facemask and face, which could
prevent medication delivery altogether.
(http://www.monaghanmed.com/AeroChamber-Plus-Flow-Vu-aVHC2)
About
the study
Data
for more than 18,000 patients with an asthma diagnosis were analysed
from the QuintilesIMS Real-World Data Adjudicated Claims Database
(PharMetrics Plus) between 1/2010 and 8/2015-9,325 using the
AEROCHAMBER PLUS® FLOW-VU® antistatic VHC and a propensity-matched
comparison cohort of 9,325 non-antistatic VHCs. Exacerbation incident
rates (IR), time to first exacerbation using Kaplan-Meier survival
analysis, occurrence of exacerbations, and healthcare resource use
and costs were compared.
• Exacerbation
IR/100 person-days (95% CI) was significantly higher in the control
device cohort than the antistatic chamber cohort (0.161 [0.150-0.172]
vs.0.137 [0.128-0.147]); more patients in the antistatic chamber
cohort remained exacerbation free.
• 4,293
patients in each cohort were followed up for (greater than or equal
to)12 months, during which there was a trend for patients in the
antistatic VHC group to be less likely (10-12%) to experience an
exacerbation. Fewer patients using the antistatic VHC had an ED visit
compared with those in the control group (10.8% vs. 12.4%).
• Exacerbation-related
costs for the antistatic VHC cohort were 23%, 25%, 20%, and 12% lower
than the control device cohort at 1, 6, 9, and 12 months,
respectively.
For
clinical inquiries, please contact:
Dominic
P. Coppolo, MBA, RRT, FAARC
Vice
President Clinical Strategy and Development
Monaghan
Medical Corporation
1-800-343-9071
Words
or phrases accompanied by ® are trademarks and registered trademarks
of Monaghan Medical Corporation or an affiliate of Monaghan Medical
Corporation. © 2017 Monaghan Medical Corporation.
References
1
Nagel MW, Suggett JA. Equivalence evaluation of valved holding
chambers (VHCs) with albuterol pressurized metered dose inhaler
(pMDI). Respiratory Drug Delivery Europe; April 25-28, 2017, 2017;
Nice, France.
2
Burudpakdee C, Kushnarev V, Coppolo D, Suggett J. A retrospective
study of the effectiveness of the AeroChamber Plus® Flow-Vu®
Antistatic Valved Holding Chamber for asthma control. Pulmonary
Therapy. 2017. http://doi.org/10.1007/s41030-017-0047-1.
Accessed July 14.
3
Asthma Facts. United States Environmental Protection Agency.
EPA-402-F-04-019. May 2017.
4
Global Initiative for Asthma: Global strategy for asthma
management and prevention, 2017. Available from:
http://ginasthma.org/2017-gina-report-global-strategy-for-asthma-management-and-prevention
Accessed November 2017.
5
Price D, Bosnic-Anticevich S, Briggs A, et al. Inhaler competence in
asthma: common errors, barriers to use and recommended solutions.
Respiratory Medicine. 2013;107(1):37-46.
6
Fink JB, Rubin BK. Problems with Inhaler Use: A Call for Improved
Clinician and Patient Education. Respir Care
2005;50(10):1360-74.
7
Lavorini F, Fontana GA. Targeting drugs to the airways: The role of
spacer devices. Expert opinion on drug delivery.
2009;6(1):91-102.
8
Mitchell JP, Coppolo DP, Nagel MW. Electrostatics and inhaled
medications: influence on delivery via pressurized metered-dose
inhalers and add-on devices. Respiratory care.
2007;52(3):283-300.
9
Chung KF, et al. International ERS/ATS guidelines on definition,
evaluation and treatment of severe asthma. European Respiratory
Journal 2014 ;43:343-373.
10
Ari A, et al. Aerosol Delivery Device Selection for
Spontaneously Breathing Patients:2012. Respir Care 2012;57(4):613-
626.
11
Levy ML, et al. Asthma patients' inability to use a pressurized
metered-dose inhaler (pMDI) correctly correlates with poor asthma
control as defined by the Global Initiative for Asthma (GINA)
strategy: a retrospective analysis. Prim Care Respir J. 2013;
Dec;22(4):406-11.
12
Ammari WG, et al. Evaluation of asthma control, parents' quality of
life and preference between AeroChamber Plus and AeroChamber Plus
Flow-Vu spacers in young children with asthma. J Asthma 2015;
52(3):301-7.
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